This post does not come from the Reed Smith side of the blog.

 

Favorable New Jersey appellate court decisions in product liability cases are almost always worthy of mention here. So we bring you Goodson v. C.R. Bard, 2018 WL 1370652 (N.J. App. Div. Mar. 19, 2018). To be truthful, we’re bringing it back to you. Bexis discussed the trial court’s decision to grant summary judgment to defendants last year.

As we discussed then, this is a case involving mesh used in hernia procedures. The particular mesh product involved in this case is not involved in the pelvic mesh MDL proceedings. And that may be reflected in the strength of the plaintiff’s expert reports, which is to say that they are not strong at all.  While the plaintiff used experts who have been involved in the pelvic mesh MDL, not one of them seemed to give the right opinions.

In particular, even though plaintiff brought a design defect claim, none of his experts gave an opinion that the design of this particular product was actually defective or that such a defect caused the plaintiff’s injuries. Id. at *4-5. Rather, his experts simply described various alleged risks of the product. This is not even close to sufficient to support a design defect claim. Id. Nor did any of the experts opine that there was a safer, feasible alternative design. Id. Similarly, even though plaintiff also brought a negligent failure to wan claim, none of the experts gave an opinion on the standard of care for issuing a warning or whether defendants met that standard. Id. at *5-6. In other words, plaintiff didn’t have a warnings expert to opine on whether the warning was adequate.

In short, plaintiff’s experts struck out looking.

To make matters worse, the treating doctor testified that he was aware of the potential risks of this mesh product and informed plaintiff of them. Id. at *6. There goes proximate causation under the learned intermediary doctrine.

Accordingly the New Jersey appellate division upheld the trial court’s grant of summary judgment to defendants. Unfortunately, it designated its opinion “not for publication.” That’s too bad. But rest assured: it happened. Westlaw already has it on-line. And the trial court’s decision, which Bexis’s post from last year lays out in considerable detail, has an excellent analysis of all the weaknesses in plaintiff’s case, an analysis that was essentially adopted by the Appellate Division. And, of course, we’ve written on it twice now. With all of that, we’re confident that you’ll find some way to make use of this appellate decision in your cases.

This post is from the non-Dechert side of the blog.

While the recent Pennsylvania Superior Court Risperdal decision is not a defense victory, it is certainly not as favorable for plaintiffs as they are making it out to be. While several issues were presented for appeal in Stange v. Janssen Pharms., Inc., 2018 Pa. Super. LEXIS 11 (Pa. Super. Jan. 8, 2018), the most important one was whether the trial court was incorrect in applying New Jersey law to plaintiff’s punitive damages claim. While plaintiffs are characterizing the decision as answering that question in the affirmative, what the court really said was maybe.

In the consolidated In re Risperdal litigation pending in the Philadelphia Court of Common Pleas, the coordinating judge granted defendants’ motion for summary judgment on punitive damages finding that the law of New Jersey, defendant’s principal place of business, applied and that under the New Jersey Product Liability Act, punitive damages are precluded in cases involving FDA approved products. Id. at *32-33. In opposition to defendants’ motion, plaintiffs argued the law of the case doctrine or in the alternative that the court should apply Pennsylvania law instead. Id. Their law of the case argument was based on the judge’s decision in three prior Risperdal cases to apply the punitive damages law of plaintiff’s home state. Id. at *35n.6. The trial court ruled that those cases were separate cases and therefore law of the case did not apply or if they were considered the same case as In re Risperdal, the same judge made all four rulings and a judge is entitled to revisit his earlier rulings “without running afoul of the law of the case doctrine.” Id. (citation omitted).

With that ruling in place, the Stange case went to trial with no punitive damage claim. Stange is a resident of Wisconsin which is where he was prescribed Risperdal and treated for his alleged injury, gynecomastia. Unlike New Jersey, Wisconsin does not have a bar on punitive damages for FDA approved products. Under Wisconsin law, however, punitives would be capped at twice the amount of any compensatory damages or $200,000, whichever is greater. Id. at *42. So, there is a clear conflict of law.

On appeal, plaintiffs argued that the trial court’s global ruling on punitive damages was improper because Pennsylvania law on choice of law requires an analysis of which state has the greatest relationship and interests in each individual plaintiff’s case and that that analysis supports applying plaintiff’s home state’s punitive damages law. Id. at *33. Plaintiffs did not argue for application of Pennsylvania punitive damages law on appeal. Id. at *43n.8. Defendants argued that plaintiffs’ choice of law argument had been waived because it was first raised in plaintiffs’ motion for reconsideration of the global punitive damages ruling. Id. at *37. The Superior Court, however, found plaintiffs’ arguments preserved. In the context of their law of the case doctrine argument which urged the court to follow its earlier decision to apply plaintiff’s home state law, plaintiffs “argued more generally that the law of the plaintiffs’ various home states should apply to punitive damages.” Id. at *39.

So, what the Superior Court concluded was that the choice of law analysis was not waived and that a choice of law analysis as between New Jersey and Wisconsin needed to be undertaken:

the trial court only considered whether New Jersey or Pennsylvania law should apply, not the law of the individual plaintiff’s home state. We agree with Stange that it is necessary to remand for the trial court to allow Stange to develop an individual record on choice-of-law as it relates to his unique circumstances and to set out the facts and state interests important to his particular case.

Id. at *45. Nowhere in the decision does the court make any finding with regard to what the outcome of the choice of law analysis should be on remand, only that the analysis needs to be done. There is nothing prohibiting the trial court from reaching the conclusion in Stange that it did in In re Risperdal globally – that New Jersey has the more significant relationship and interests on the punitive damages claim. Indeed, having reached that decision once already we struggle to understand how the facts of any particular case will impact the court’s analysis. For the underlying substantive claims, most choice of law analyses will favor plaintiff’s home state – where he was prescribed, where he suffered his injury, where he was treated. But the alleged corporate misconduct giving rise to the claims for punitive damages occurred in New Jersey. It is there that the company developed the Risperdal labeling and its marketing and sales strategy and from there that it had communications with the FDA. Id. at *44.  So, even on a case-by-case basis, there is ample support for a finding that in a failure to warn case, the proper focus for purposes of a choice of law analysis on punitive damages is the place where the alleged corporate misconduct occurred.

So we think plaintiffs are celebrating a bit prematurely. The Stange decision may have removed the foil and even loosened the wire cage, but the cork remains in place.

As we noted at the outset, punitive damages choice of law was not the only issue on appeal and so we make passing mention of two other noteworthy aspects of the case. First, defendants challenged the trial court’s admission of certain expert testimony on the grounds it did not meet Frye standards. Id. at *8-9.  The Stange, court however erroneously applied the novelty limitation from Trach v. Fellin, 817 A.2d 1102 (Pa. Super. 2003) – that Frye only applies to the most “novel” of scientific testimony. That narrow interpretation was rejected by the Pennsylvania Supreme Court in Betz v. Pneumo Abex LLC, 44 A.3d 27 (Pa. 2012), a case not cited in Stange.

Second, it was agreed that Wisconsin law governed the substantive claims in the case. While examining the issue of proximate cause on failure to warn, specifically whether plaintiff had carried his burden of proving a different warning would have changed plaintiff’s prescribing physician’s decision to prescribe, the court applied the learned intermediary rule which has never been adopted by any appellate court (only trial courts, which have split) under Wisconsin law. Id. at *22n.4 (no conflict between Pennsylvania and Wisconsin law on the scope of learned intermediary doctrine). We’ll add it to our learned intermediary “head count.”

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog.  Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions by intermediate courts of appeals.  As always, our guest posters are 100% responsible for what they write – due 100% of the credit, as well as any blame.  Take it away Kevin.

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SCOTUS Calls For Solicitor General’s Views In Third Circuit Fosamax Case

Friday December 8 was a day with two items that are particularly noteworthy because of their potentially momentous implications. Remember the Blog’s previous lambasting of the Third Circuit’s unprecedented Fosamax preemption decision and the haymaker that court unleashed on the drug and device industry, in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017)?  Now, there is positive news to report. The Supreme Court has invited the Solicitor General “to file a brief in this case expressing the views of the United States.” Merck, Sharp & Dohme Corp. v. Albrecht, et al., No. 14-1900 (Order, Dec. 8, 2017).

What is that? Here is SCOTUSBlog’s description:

“CVSG” stands for “call for the views of the Solicitor General.”  In most cases in which someone is seeking review of the lower courts’ decision, the Court will issue a straightforward grant or denial.  But sometimes the Court will want the government’s views on what it should do in a case in which the government isn’t a party but may still have an interest — for example, because the interpretation of a federal statute is involved.  So the Court will issue an order in which it “invites the Solicitor General to file a brief expressing the views of the United States.”  It isn’t an “invitation” in the sense that the federal government gets to decide whether it wants to file a brief at all, because the Court expects the government to file.  There is no deadline by which the government is required to file the brief, however.  And the government’s recommendation, although not dispositive, will carry significant weight with the Court.

In Fosamax, this development is important because it signals that the case stands out from the general certiorari pool, meaning that review is more likely to be granted.  Statistics are surprisingly hard to come by, but a law review article, Thompson & Wachtell, “An Empirical Analysis of Supreme Court Certiorari Petition Procedures:  The Call for Response and the Call for the Views of the Solicitor General,” 16:2 G. Mason L.R. 237 (2009), analyzed ten years of Supreme Court cases (1994-2004) and concluded:

The overall grant rate increases from 0.9% to 34% following a CVSG from the Court; in other words, the Court is 37 times more likely to grant a petition following a CVSG.  For petitions on the paid docket, the grant rate increases even more, to 42%; a paid petition is 47 times more likely to be granted following a CVSG.

Id. at 245 (emphasis added).  If those somewhat dated statistics are even close to currently accurate, the Fosamax CVSG is a big deal.

Recall that the Third Circuit grossly misinterpreted the “clear evidence” preemption test from Wyeth v. Levine, which held that without clear evidence that the FDA would not have approved the label change, a court cannot rule a manufacturer’s compliance with federal and state law is impossible, and thereby preempted, already an exacting defense.  As the Blog explained in praising the petition for certiorari, the Third Circuit distorted Levine, applied an unprecedented standard, and ruled that a manufacturer could not invoke preemption without “clear and convincing” evidence that the FDA would have rejected a proposed warning.  Thus, not only did the Third Circuit reverse summary judgment for the manufacturer in more than 1000 cases, it rendered impossibility preemption even more difficult than the anti-preemption justices in Levine intended.  The Blog also discussed the Product Liability Advisory Council’s amicus brief in support of the petition here, which explained that the Third Circuit’s decision invites further lower court confusion, obliterates the district court’s ruling that was supported by undisputed evidence, encourages pharmaceutical manufacturers to flood the FDA with proposed label changes, and threatens to stifle the innovation necessary to develop new, potentially life-saving drugs.

This latest development raises defense hopes that SCOTUS will grant the petition, and finally reverse one of the worst decisions of 2017, which would be a huge win for the manufacturer in particular, and of greater significance for the big picture for pharmaceutical companies and consumers in general. Stay tuned.

New Jersey Supreme Court Grants Review of Accutane Cases

Also on December 8, the New Jersey Supreme Court granted the appeals in all of the Accutane cases that the appellate court revived back in July. The Blog has monitored the Accutane litigation through many of the twists and turns of its tortuous existence for more than a decade, first with the Accutane MDL, and then with the New Jersey cases.  As a resident of the San Francisco Bay Area, when I think of the Accutane litigation, I automatically picture Lombard Street, often touted “The Crookedest Street In The World,” with its eight hairpin turns and switchbacks that span the 600 feet of the street’s natural 27° grade.  In fact, Lombard Street is not even the most crooked street in San Francisco, because Vermont Street, has a greater sinuosity at 1.56 versus 1.2 for Lombard, though Vermont at seven turns, has one fewer than its more famous cousin.   Lombard Street and its adornment of brick red and beautiful flowers attracts thousands of tourists per year.  This meandering avenue is difficult to traverse, requires careful navigation, has been around a long time, and produced extreme frustration for those who occupy it: if it sounds familiar, bear in mind that the Accutane litigation likewise has a lengthy history, ongoing since 2003, has zigged and zagged, and neither side is particularly thrilled with the results.  The Blog has discussed many of the good aspects here, (vacating plaintiff verdicts) here, (dismissals based on learned intermediary doctrine) here, (MSJ granted) and here (warnings adequate as a matter of law), as well as the very bad Appellate Division decisions earlier this summer, when the court reinstated more than 2000 causation based dismissals.

With that in mind, here is a very brief summary of the mind-bending history of the Accutane saga and the battle over the proper expert testimony that has hopefully neared its dénouement.  As already discussed at length, the Appellate Division reversed the trial court’s decision that excluded plaintiffs’ expert causation testimony, reviving more than 2000 lawsuits.  Not surprisingly, the manufacturer appealed, supported by amicus briefs from 21 of New Jersey’s largest employers, including many Roche competitors, the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, the American Medical Association, and eight scholars and professors of law.  When it comes to expert testimony, New Jersey unfortunately travels The Road Not Taken, applying a “relaxed” standard of expert testimony in toxic tort cases, as set forth in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), rather than the more rigorous federal Daubert standard.  Under Rubanick, expert testimony may be admitted “even though it is controversial and its acceptance is not widespread,” only if “it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field.”  Id. at 447.  In Kemp v. State, 174 N.J. 412, 425-426 (2002), the court ruled that the inquiry was not based on reasonableness, but instead examines “whether comparable experts in the field [would] actually rely on that information.  Kemp, 174 N.J. at 426 (citations and quotations omitted).  Since Rubanick and Kemp, New Jersey courts have continued the state’s unique application of scientific expert testimony with an approach distinct from the more exacting federal standard, resulting in inconsistency, confusion, and the morass of the Accutane litigation.

As the Blog discussed, and the amici explained, the Accutane trial judge applied a standard similar to Daubert, but the Appellate Division reversed the decision based on Rubanick. In so doing, the appellate court essentially ignored the gold standard of scientific evidence, epidemiological studies all but one which failed to “demonstrate[] a statistically significant increased risk of developing Crohn’s disease.”  In re Accutane Litigation, 451 N.J. Super. 153, 168  (App. Div. July 28, 2017).  Nonetheless, the Appellate Division allowed the plaintiffs’ experts to rely on evidence that should have been excluded as unreliable, such as animal studies, anecdotal case reports, and analogous medicines – in other words, scientifically unsound data.  Id. at 165-166.  Similarly to the Fosamax decision, this represents not only bad law and bad precedent, but also has far-reaching implications.  Pharmaceutical manufacturers and health professionals resoundingly decried the Accutane decision as one that will stifle research and development, and the practice of medicine out of the uncertainty of scientific evidence, and fear of legal reprisals.  The amici implored the New Jersey Supreme Court to adopt Daubert’s methodology to reaffirm the trial court’s role as a gatekeeper to ensure that only reliable scientific evidence informs the jury’s decision.  Again, the industry can take heart in the court’s order granting review of the Appellate Division’s abysmal decision, and hope that the New Jersey Supreme Court will allow modern scientific principles, rather than the unreliable and questionable methods, to govern expert testimony.  If that occurs, no doubt will the New Jersey high court reinstate the trial court’s ruling, and order dismissal of the more than 2000 cases for lack of  causation evidence.

This guest post is by Reed Smith‘s Devin Griffin.  It deals with an important pending appeal in New Jersey’s version of Jarndyce v. Jarndyce – Accutane litigation.  As always with our guest posts, the author is 100% responsible for what follows, deserving of all the credit, and any blame.  Take it away Devin.

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The Accutane litigation in New Jersey has been covered closely by this Blog for its duration. The Blog’s most recent Accutane post evaluated the Appellate Division’s decision to reverse the trial court’s order excluding certain plaintiff causation expert witnesses—a ruling that resulted in the revival of over 2000 cases.  That post explained that the Appellate Division has proposed a “relaxed” standard for the admissibility of expert opinions, and that the application of this standard (i.e., the types of evidence that experts may rely upon in rendering their opinions) should evolve as more epidemiological studies (or the “gold standard” of scientific evidence) become available.  The post explained that this has not occurred in the Accutane litigation.  With the recent Appellate Division decision, it is clear that the New Jersey appellate court is attempting to impose its own unique standard that disregards the hierarchy of evidence, allowing animal studies and single-person case studies to be afforded the same weight as vast epidemiological studies.  With the submission of four separate amicus curiae briefs to the Supreme Court of New Jersey by companies and groups spanning different industries and health-related interests, it has become clear that this Blog is not alone in feeling displeasure over the Appellate Division’s recent decision.  This is something that the New Jersey Supreme Court definitely needs to review, both as to the questionable legal basis for the decision and its negative impact on some of the state’s largest employers.

Before delving into the substance of the amicus briefs, it is useful to revisit court decisions relevant to this case. In Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), the New Jersey Supreme Court established the applicable standard for reviewing expert testimony in toxic tort cases.  Rubanick stated that an expert’s opinion may be admissible “even though it is controversial and its acceptance is not widespread,” but only if “it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field.”  Id. at 447.  Rubanick created the so-called “relaxed” standard – with the “relevant field” seeming to be litigation testimony − declining to adopt the standard set forth in Rule 703 of the Federal Rules of Evidence.  Then, in Kemp v. State, 174 N.J. 412 (2002), the court stated that “the appropriate inquiry is not whether the court thinks the expert’s reliance on the underlying data was reasonable, but rather whether comparable experts in the field [would] actually rely on that information.  Kemp, 174 N.J. at 412 (citations and quotations omitted).  Since Rubanick and Kemp, New Jersey courts have continued to approach scientific expert testimony under a “Daubert lite” analysis that diverges significantly from the science-based federal approach to expert testimony.  As a result, much confusion and inconsistency in New Jersey case law has ensued.

The Accutane litigation represents the culmination of the resulting confusion and inconsistency in the New Jersey expert witness standard.  In addressing the admissibility of expert witness testimony, the Accutane trial court applied a standard ostensibly similar to the federal Daubert standard without expressly adopting the federal test.  However, the Appellate Division reversed the trial court decision, citing Rubanick’s “relaxed” standard.  By applying that relaxed standard, the Appellate Division effectively disregarded the hierarchy of evidence and gave equal weight to the Plaintiff experts’ evidence, which mostly consists of animal studies and case reports, as it did to the extensive body of exhaustive and robust epidemiological studies relied upon by Roche’s experts.   That result is a poor parody of the scientific method.

The practical effect of this Appellate Division decision will result in the admission of expert witness testimony that deserve to be excluded as unsound, and that has in fact been excluded in federal court on precisely that ground.  Since the Blog’s last Accutane litigation post, the defendant has sought further review in the New Jersey Supreme Court.  Recent amicus brief filings indicate that we are not alone in our worry.  Amici from various life science and medical industries recently joined forces to urge the court to reconsider the Appellate Division decision—specifically the decision of what standard should be applied to the admissibility of expert witness testimony.  Notably, a remarkable array of groups including the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, twenty-one of New Jersey’s largest employers, the American Medical Association, and eight scholars and professors of law have joined forces to file amicus briefs that urge the New Jersey Supreme Court to abandon the anachronistic and peculiar “relaxed” standard for the federal standard.  The perspectives of amici claiming a stake in the litigation are detailed below.

New Jersey’s business sector weighed in two separate briefs. In one brief, twenty-one of New Jersey’s largest companies (many of whom are each other’s competitors) submitted an amicus brief supporting Defendant Roche.  The twenty-one signatory companies include the likes of Allergan, Bayer, Bristol-Myers Squibb, C.R. Bard, Merck, Honeywell, GlaxoSmithKline, Quest Diagnostics, Pfizer, and Verizon.  These businesses provided their perspectives on the Appellate Division’s decision.  The companies argue that the decision would have the effect of allowing inconsistent rulings.  The companies stated that they as companies choose to conduct extensive business in New Jersey and should not suffer the uncertainty and inconsistency in causation rulings that the “relaxed” standard’s dumbing down of the scientific method encourages.  The companies explain that the Appellate Division’s standard would allow plaintiffs experts to “cherry-pick” data, or rely on studies that support their result-oriented opinions while ignoring the sweeping and conclusive studies that conflict with their propounded opinions.  Ultimately, the companies highlight the importance of expert admission standards to New Jersey business, stating that over the past two years alone, companies have been forced to spend nearly $4 billion defending against New Jersey products liability suits.  These amici warn that, should the Appellate Division’s decision be upheld, the impact would be felt far beyond the courtroom.  Loose admission standards for expert testimony will adversely affect the “very real public benefit derived from the products” that these companies manufacture.

In the other business sector brief, the HealthCare Institute of New Jersey, New Jersey Business and Industry Association, the Commerce and Industry Association of New Jersey, and the New Jersey Chamber of Commerce weigh in on the errors of the Appellate Division.  Notably, these amici address the confusion in New Jersey case law regarding what standard to apply in assessing expert witness testimony.  These amici state that the New Jersey Supreme Court and its Committee on the Rules of Evidence have studied the question presented by the recent Appellate Division decision as early as 2000, but the court failed to provide a conclusive answer, because it was waiting for a hard-fought adversarial case to address this question.  To these amici, it is abundantly clear that this is exactly the zealously litigated adversarial setting that the court has been waiting for.  In their critique of the Appellate Division decision, the organizational amici state that by allowing the Appellate Division decision to stand, the court is allowing “junk science” to be presented to lay juries.  Most significantly, the amici discuss how the Appellate Division’s proposed standards for the admissibility of expert testimony would subject defendants to extensive civil liability by allowing juries to challenge exhaustive, FDA-approved, scientific evidence with opinions based on novel and unsupported theories that the FDA would never permit.  Ultimately, these amici urge the court to adopt Daubert to reinstate the court’s role in gatekeeping to prevent further litigation-driven expert opinion testimony from clouting this science-based field.

Next, eight legal scholars and professors of law (“the scholars”) urge the New Jersey Supreme Court to clear up the confusion that has ensued as a result of the “relaxed” standard.  The scholars detail the benefits of New Jersey adopting rule 702 of the Federal Rules of Evidence.  The scholars contend that adoption of the federal Daubert test is especially important in toxic tort cases because a jury will likely be unable to wade through the sophisticated terminology and standards that these cases present.  By depriving the jury of the tools it needs in complex litigations of this type, the “relaxed” standard allows precedent that equates the scientific value of anecdotal evidence with gold standard epidemiology.  The scholars point out  that, while the Appellate Division freely cites to federal decisions such as Daubert in its decisions, it simultaneously unmoors those decisions from their foundation by disregarding the very federal gatekeeping requirements that make those decisions persuasive – thereby adding to the confusion within New Jersey case law in this area.  The scholars warn that if this decision is upheld, the role of court in excluding unreliable testimony will effectively be eliminated.

Finally, organizations representing physicians, both in New Jersey and nationwide, weigh in with their own amicus brief.  Six different federal and state-based medical societies join to urge the New Jersey Supreme Court to reconsider this decision.  These amici argue that the Appellate Division’s decision is not only contrary to legal precedent, but more importantly does violence to well-established scientific principles.  The medical amici explain that the hierarchy of evidence is vitally important to evidence-based medicine and science.  According to these amici, whether evidence being considered in expert opinions has been subject to peer review is key to assessing its reliability.  Notably, the medical amici establish that scientific consensus is a strong indicator of good science and that the Appellate Division erred in ignoring the consensus relied upon by Roche’s expert witnesses.  These medical amici warn strongly of the profound impact that this decision could have on medical practice in New Jersey.  These amici discuss that this decision will further complicate the patient-doctor relationship because now doctors will be forced to address and debunk unproven theories during informed consent discussions with their patients.  Doctors will likely feel the need to address these unsupported theories for fear of being sued.  Lastly, doctors may simply choose to forgo certain reliable treatments altogether.  The medical amici state that this decision endangers patients who need treatments, especially where there is a lack of other treatment options as is the case with Accutane and severe cystic acne.

This Blog has been quite critical of the latest twist in the seemingly unending saga of Accutane litigation in New Jersey. Thus, it is gratifying to find amici representing such a large cross-section of New Jersey’s business, life science, and healthcare industries coming together to voice their disapproval as well.  The Appellate Division’s decision nullifies any meaningful gatekeeping role for the New Jersey judiciary and, if allowed to stand, will have the harmful effect of letting any hired expert share scientifically unsupported opinions with all future juries.  With this kind of support, the odds increase that the New Jersey Supreme Court will appreciate the importance of removing junk science from state courts and will accept review in Accutane to reinstate the fundamental principles of science and the hierarchy of evidence in New Jersey courts.

The court may have taken a relaxed approach, but its decision has done nothing but raise blood pressures over at that DDL blog. The course of the Accutane litigation in New Jersey has been labored and we’ve posted about the whole journey. For years, we were pretty riled up. The news from the coordinated proceeding in the trial court had been very bad, including a few large plaintiff verdicts. Then the litigation got reassigned and under new management the tide began to turn. We could feel our pulse returning to normal. The new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. Indeed, the Appellate Division has vacated at least a half dozen plaintiff verdicts. After so many tortuous years, defendants in the New Jersey Accutane litigation finally had a reason to smile (actually thousands of reasons if reasons are dismissals). So we definitively can say we were unpleasantly surprised when last week the Appellate Division reversed the trial court’s order excluding certain plaintiff causation expert witnesses resulting in reviving over 2000 cases.

The to-be-published decision can currently be found at In re Accutane Litigation, 2017 N.J. Super. LEXIS 116 (App. Div. Jul. 28, 2017). It’s a long opinion with a lengthy discussion of epidemiology in general and the epidemiologic evidence pertaining to Accutane specifically. We’ll try to just hit the relevant highlights.

First a quick primer on New Jersey law on the admissibility of expert evidence. New Jersey has adopted a “relaxed” general acceptance standard for toxic tort and pharmaceutical cases. See Rubanick v. Witco Chemical Corp., 125 N.J. 421, 449 (1991). That means that if the expert’s theory is not generally accepted, it may still be admissible if it is “based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.” In re Accutane, at *47. Further, specifically in regard to reliance on epidemiology as evidence of causation, the court must address not just methodology but also the expert’s reasoning in applying or relying on that methodology to reach his/her conclusions. Id. The court should not only review the studies and other information to determine if they are the type of data experts ordinarily rely on but also “examine the manner in which experts reason from the studies and other information to a conclusion.” Id. at *51.

As we mentioned, the litigation has been handled by two different trial judges. The first judge allowed the opinions of plaintiffs’ experts based on the same type of evidence relied on by plaintiffs’ experts here. Id. at *5. But this litigation has been pending for 14 years. The science has not been stagnant during that time. From 2003 to 2009, there were no epidemiological studies regarding Accutane and irritable bowel disease (IBD) or Crohn’s disease. Id. at *8. Epidemiological studies are considered at the top of the scientific hierarchy. Experimental studies (double-blind randomized control trials) are the gold standard and observational studies (case-control or cohort studies) are the next best available evidence. Without those, plaintiffs’ experts were permitted to rely on “animal studies, human clinical studies, case reports, class effects, published scientific literature, causality assessments, and biological plausibility.” Id. In other words, they were permitted to use less reliable evidence because that is all there was.

But in 2009 and 2010, the first epidemiological studies were published – both of which found no statistically significant increased risk for developing Crohn’s disease from the use of Accutane. Id. Six more epidemiological studies followed and while the results vary, “with one exception, none of them demonstrates a statistically significant increased risk of developing Crohn’s disease.” Id. at *9. Despite the evolving state of the science, plaintiffs’ experts chose to discount the epidemiology in favor of the “other information” on which they had previously relied.

Applying even the New Jersey “relaxed” standard, the trial court found that plaintiffs’ experts reasoning and methodology “slanted away from objective science and in the direction of advocacy.” Id. at *53-54. After reviewing the evidence and conducting a full Kemp hearing (New Jersey’s version of a Daubert hearing), the trial court concluded that the epidemiologic evidence did not support a reasonable inference of a causal link between Accutane and Crohn’s disease. Plaintiff’s experts ignored the studies’ authors own conclusions, excluded the larger population based studies, and made assumptions to “bridge an analytical gap in his methodology.” Id. at *54-55.

We’ve blogged before about the risk of allowing litigation to march ahead of science. As the United States Supreme Court explained in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), the goal of “reaching a quick, final, and binding legal judgment” on matters that are “often of great consequence” is not advanced by accepting hypotheses and conjectures in the place of reliable scientific evidence. But that is exactly what the New Jersey Appellate Division seems determined to do. The court announced its guiding principle as the antithesis of Daubert: “legal decision making in toxic tort and similar cases may vary from scientific decision making.”  Id. at *69. This doesn’t even reconcile with the New Jersey standard that requires general acceptance in the scientific community of an expert’s methodology and reasoning.

And what happens when “legal decision making” supplants the scientific process? Experts get to do things differently in the courtroom than in practice. They can ignore big epidemiologic studies not finding a statistically significant relationship for little ones that do, as long as they come up with some critique of the larger studies that lets them.  They can use data further down the “hierarchy” even though top tier evidence is against them.  They can rely upon their clinical experience in deciding what evidence accords with it. Precisely the types of things Daubert, Rubanick, and Kemp say should not be permitted.

Further, while giving lip service to the fact that “science is constantly evolving” and that “legal decisions need to be made based on the best evidence available at the time of the decision” – the court seems to be mired in the past. Id. at *69. It concludes that despite the overwhelming epidemiological evidence that demonstrates no statistically significant increase in the risk of Crohn’s disease from taking Accutane, plaintiffs’ experts can continue to rely on “other types” of evidence – “which in this same MCL docket they were previously permitted to use.” Id. at *70. Why is that part of the equation? As much as litigation shouldn’t lead science, it shouldn’t lag it either. It should move with it. The state of the science is vastly different than it was 14 years ago, and the court seems to be willing to overlook those developments. The opinion states that the decision “must be viewed in the context of this particular MCL litigation” and “concern[s] the survival of plaintiffs’ cause of action in the face of new scientific information.” Id. at *68-69. Exactly. Plaintiffs’ claims need to be assessed on the basis of the new scientific evidence. And if the claims can no longer survive based on the evolving scientific evidence, then that is the result. Ultimately, however, what seemed to matter more than accurately applying the law to the current state of the science, was “[t]he opportunity of thousands of plaintiffs, claiming injury from Accutane, to have their day in court.” Id. at *69.

The Supreme Court’s opinion on personal jurisdiction in BMS v. Superior Court has already made a substantial impact, despite being on the books for a mere three weeks.  That’s probably because it’s the Supreme Court and also because personal jurisdiction is an issue in every lawsuit filed, whether in state or federal court.  Another reason could be that the California Supreme Court’s opinion reaching for personal jurisdiction in BMS was so clearly swimming against the Supreme Court’s recent current that its reversal was widely anticipated and thus gained notoriety even faster than usual.  That last part is speculation, but still, we have not heard so much about personal jurisdiction since poor Mr. Burnham traveled from New Jersey to California to visit his kids. See Burnham v. Superior Court, 495 U.S. 604 (1990).

So what will we see following BMS?  We saw last week that some plaintiffs will try to stretch even the most tenuous forum contacts into specific jurisdiction, and some courts may go along with that.  We expect that most will not.  Take for example a recent opinion from the New Jersey Appellate Division, Dutch Run-Mays Draft, LCC v. Wolf Block, LLP, __ A.3d __, 2017 WL 2854420 (N.J. App. Div. July 5, 2017).  In Dutch Run, a Florida real estate developer sued a dissolved Pennsylvania law firm in New Jersey state court, and it argued that the law firm’s compliance with New Jersey’s business registration statute created personal jurisdiction “by consent.”  The New Jersey courts rejected that position.  Sure, the plaintiff was able to identify New Jersey contacts—business registration, a New Jersey registered agent, two New Jersey offices, the residency of some partners on the law firm’s dissolution committee, and three lawsuits that the law firm filed in New Jersey’s courts.

The problem for the plaintiff was that its claims had nothing to do with these New Jersey contacts. As the court put it, “[T]he negligence forming plaintiff’s cause of action did not arise from defendant’s contacts with New Jersey.  Plaintiff cannot show any relationship between the underlying matter and the business or attorneys in New Jersey.” Id. at *5.  Thus, no specific personal jurisdiction.  This is a faithful application of BMS, which requires a causal link between the defendant’s forum contacts and the plaintiff’s alleged injury.

Equally as important, the court held that the law firm’s registration in New Jersey did not imply “consent” to general personal jurisdiction under Daimler AG v. Bauman:

Plaintiff suggests Daimler’s holding is narrowed by its facts, specifically that Daimler was not registered as a foreign entity and had no registered agent or offices in California.

This limited view ignores Daimler’s definitive due process analysis. . . .  We now join the many courts that have circumscribed the view of general jurisdiction post-Daimler. . . .  In light of Daimler, we reject the application of [Allied-Signal, Inc. v. Purex Indus., Inc. 242 N.J. Super. 362 (App. Div. 1990)] as allowing general jurisdiction solely based on the fiction of implied consent by a foreign corporation’s compliance with New Jersey’s business registration statute. . . .  Importantly, the exercise of general jurisdiction requires satisfaction of the “continuous and systematic contacts” to comply with due process. Mere registration to conduct some business is insufficient.

Dutch Run, at *7 (emphasis added, citations omitted).  The court also rejected the plaintiff’s request for “jurisdictional discovery” because “[w]e remain unconvinced that permitting further discovery would have altered our conclusion.” Id. at *8.

Speaking of discovery, we also commend to you the order rejecting “jurisdictional discovery” in In re Baltimore City Asbestos Litigation (Smith v. Automotive Prods. Co.), Memorandum Opinion & Order, No. 24X13000333 (Baltimore City Circuit Ct. June 7, 2017).  In Smith, a Pennsylvania plaintiff sued multiple Pennsylvania defendants in Pennsylvania.  But after some defendants won summary judgment, the plaintiff tried to re-file his lawsuit in Maryland, which has a longer statute of limitations.  Slip op. at 2.

The Maryland court initially reserved ruling on personal jurisdiction and allowed limited “jurisdictional discovery.” This made neither side happy, resulting in dueling motions for reconsideration:  The defendants asked again for dismissal, and the plaintiffs wanted broader discovery.

The defendants won. Citing BMS, the court ruled that it lacked specific personal jurisdiction over the defendants because

this suit is unrelated to any alleged contact the Defendants may have had with the State of Maryland. Further the Defendants in this suit have conducted virtually no business in the State of Maryland and, therefore, have not purposefully availed themselves of the privilege of conducting activities in the State.  Therefore, this Court lacks specific jurisdiction over the Defendants in this suit.

Slip op. at 5. The court similarly lacked general personal jurisdiction over the defendants because they were not “at home” in Maryland, where “the only relevant inquiry is whether the defendant is either incorporated or has its principle place of business in the forum state.”  Slip op. at 6 (citing Daimler AG v. Bauman).  Like the New Jersey court in Dutch Run, the Maryland court rejected “jurisdictional discovery” because “[i]t is clear that further discovery will not uncover facts demonstrating the existence of general jurisdiction over any of the moving Defendants.  All of the Defendants are incorporated outside of Maryland.  The Defendants’ principal places of business are all in Europe.”  Slip op. at 6.

We bring you these two cases not only because they are timely, but because they confront tactics that we expect to see post-BMS—assertions of jurisdiction “by consent” and requests for “jurisdictional discovery.”  Our view on jurisdiction by consent is clear:  We don’t think it holds up; and as the New Jersey court found, a majority of courts have ruled that business registration alone does not form consent to jurisdiction.

As for discovery, these courts were correct to reject discovery where the facts already showed that jurisdiction was lacking. To this, we can add only that courts contemplating “jurisdictional discovery” should be reticent, very reticent.  As is commonly true with phased discovery, defining the phases can be challenging, leading to substantial overlap between discovery on jurisdictional facts versus discovery on all other facts.  It is a slippery slope toward full-blown discovery, in a case where the plaintiff has not yet established the court’s jurisdiction.  Look at what the plaintiff did in Smith v. Automotive Products, discussed above—the court gave them jurisdictional discovery, and their response was to ask for more.  We are not surprised.  Of course, this all assumes that a court has the power to allow discovery against a defendant contesting jurisdiction in the first place.  We don’t know the answer to that question, but the yet-to-be established nature of the court’s prerogative is another reason to tread lightly.

No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious.  The rub is that the parties have very little to show for the effort.  The latest shoe dropped last week when the New Jersey Appellate Division vacated (again) a jury verdict in favor of an Accutane plaintiff.  The unpublished opinion in McCarrell v. Hoffmann-La Roche, Inc., No. A-4481-12T1, 2017 WL 1683187 (N.J. App. Div. May 2, 2017), is interesting, both in its treatment of expert opinion and evidence on causation under Alabama law.

But before we get to that, let’s review very briefly what has come before. When plaintiffs first started suing in earnest over Accutane, they alleged a variety of injuries, including psychiatric conditions, birth defects, kidney disorders, vision problems, and musculoskeletal problems.  There has been some litigation on these issues, but the proceedings in New Jersey and elsewhere have focused largely on gastrointestinal disease, including inflammatory bowel disease.  IBD can be every bit as bad as the name makes it sound, and we can see why patients who experience IBD can garner substantial sympathy.  But the warnings on gastrointestinal disorders are robust, and a federal court in Florida ruled in 2012 and 2013 that the Accutane warnings as to IBD were adequate as a matter of law.

But not in New Jersey, where several cases have proceeded to trial. We have not surveyed the New Jersey verdicts lately, but the last time we did, we counted about half a dozen verdicts—all of which were vacated, with others pending on appeal.  There certainly are others that we are not counting here, but the trend is unmistakable:  Multiple trials presided over by a New Jersey mass tort judge who was championed by some as a hard-working jurist and vilified by others for placing a thumb firmly on one side of the scale.  Substantial verdicts in favor of the plaintiffs.  All of them vacated.  In the mass tort context, vacated verdicts represent a massive waste of both sides’ time and money.

Which is what happened again last week in McCarrell.  The case was first tried to a jury in 2007, resulting in a verdict for the plaintiff.  But the Appellate Division vacated that award and remanded for a new trial because of erroneous evidentiary rulings. McCarrell, 2017 WL 1683187, at *1.  The parties therefore tried the case again in 2010, which resulted in a larger verdict for the plaintiff.  On appeal from the second verdict, the Appellate Division reversed again and held that the claims were time barred.  But the New Jersey Supreme Court disagreed and remanded the case back to the Appellate Division to address the remaining issues on appeal. Id. at **1-2

That remand resulted in last week’s opinion, and the Appellate Division reversed again.  First, the trial judge ordered that it would not allow duplicate expert testimony.  As a result, the defense had its expert gastroenterologist address certain studies, but was prohibited from having an epidemiologist corroborate that testimony. Id. at *2.  The rubber hit the road in closing argument when plaintiff’s counsel emphasized to the jury that the defense gastroenterologist’s opinion stood alone.  That was a problem, particularly once the Appellate Division ruled in 2013 that “trial courts should not prohibit overlapping expert testimony in complex matters on a ‘central issue of liability.’” Id. at *2 (citing McLean v. Liberty Health System, 430 N.J. Super. 156 (App. Div. 2013)).  Under that ruling, the trial judge’s decision to disallow overlapping expert testimony about scientific studies was error. Id. at *3.  And in light of counsel’s emphasis in closing on the defendants’ expert as a “lone outlier,” the error was prejudicial.

Second, the court held that the plaintiff had not met his burden of proving causation. This was a failure-to-warn case, but no one asked the prescribing physician whether her decision to prescribe Accutane would have been different if the drug had come with a stronger warning. Id. at *4.  Regular readers of the blog know this is warnings causation 101, and because the plaintiff bears the burden of proof under the applicable law (Alabama in this case), the absence of this essential evidence caused his warnings-based claims to fail as a matter of law. Id. We agree wholeheartedly with this ruling, although we are somewhat puzzled that the Appellate Division suggested going out and deposing the doctor again.  Sure, the doctor was deposed in 2007, but the burden of proving warning causation is not obscure now and was not obscure then.  It is not obvious to us that a second bite at the apple is warranted, nor do we know if the prescriber can even be re-deposed, after another decade has passed.

So what do we mean when we say that no one can be happy with this? The opinion gives parties on both sides more leeway in presenting expert testimony, and we have guidance on proving failure to warn under Alabama law.  But in the larger scheme, this case is apparently heading for a third trial, having first b een tried ten years ago.  Other verdicts from New Jersey have met the same fate.  Plaintiffs are left empty handed, and the defendants continue to bear the burden of vigorous litigation in New Jersey, whereas the federal MDL wrapped up in the defendants’ favor years ago.  In the end, McCarrell is a defense win, but the cost has been high.

When this blogger hears “negligent undertaking,” my mind does not automatically turn to products liability – but rather to pre-teen children. Pre-teen children are at the age where they are asked (actually required) to “undertake” more and more duties and responsibilities. But often these duties are undertaken in a rather haphazard or lackadaisical way that some might say rise to the level of negligence. Dishes with food left on them put back in the cabinet. Wet laundry left in the dryer for more than a day. And as for cleaning up after the dog, well enough said. And as one of the two arbiters of whether such pre-teens have failed to act in good faith, I admit to guilt in an expanding definition of what constitutes negligent undertaking. The New Jersey courts fortunately have stricter and more precise guidelines than mood and level of tolerance on any given day to guide them and those rules led them to dismiss plaintiff’s negligent undertaking claim in Nelson v. Biogen Inc., 2017 WL 1382910 (D.N.J. Apr. 17, 2017).

The product at issue is Tysabri, a drug used to treat multiple sclerosis. Patients who test positive for anti-JC Virus antibodies were shown to be at an increased for developing a certain brain infection with use of the drug. Id. at *1. Plaintiff contracted the infection after being treated with the drug for three years.

It is worth pointing out some of the procedural history here to understand that his was a bit of a hail-Mary by the plaintiffs. Plaintiff’s initial and first amended complaints contained a claim for negligence that was dismissed because in New Jersey the sole remedy for products liability is the New Jersey Product Liability Act (NJPLA). Id. at *2. All products liability claims, except express warranty, are subsumed by the Act. So plaintiff’s second amended complaint alleged design defect and failure to warn under the NJPLA. Defendants moved to dismiss the design defect claim as preempted and plaintiff withdrew the claim before the court could rule on the motion. Id.   Which left plaintiff with only a failure to warn claim in his third amended complaint. After two years of discovery, plaintiff moved to amend his complaint for a fourth time, this time to add a negligent undertaking claim.

The basis for the claim, argued plaintiff, was that defendants had entered into a licensing agreement with the NIH to allow defendants to use the NIH’s JC virus antibody assay to develop the assay for commercial use. The assay would allow doctors to test for the antibodies to determine if their patients were at an increased risk for the brain infection. Id. The licensing agreement was entered into in 2006 and defendants released their JC virus antibody assay in 2012. Plaintiff alleges that when defendants entered into the licensing agreement, they were voluntarily undertaking the duty to develop the assay and that they failed to do so in a reasonable and timely manner. Id. at *3.

First, the court held that this negligent claim, like the negligence claim in plaintiff’s original complaint, was preempted by the exclusivity of the NJPLA. Plaintiff argued that negligent undertaking was different than other negligence claims because it is not based on a pre-existing duty. Not only did plaintiff have no New Jersey or other authority for this argument, it is a distinction without merit. As the court pointed out, “the application of the NJPLA is not premised on the timing of the duties incurred.” Id. at *4. Further, most duties (unlike those in my household) are at some point voluntarily assumed. “For example, before Defendants decided to develop, market, and sell Tysabri, they had no duty to do so. Once Defendants voluntarily decided to produce Tysabri, they then had a duty to act with reasonable care in doing so.” Id. Negligent undertaking is precluded by the NJPLA.

Second, the court found it would be an unprecedented expansion of liability to use negligent undertaking to create third-party negligence obligations to non-parties to the license, or indeed to any contract.  Plaintiff cited no cases in which a party who agreed to a license was held liable for negligent undertaking. Id. at *5. Acknowledging significant policy concerns, the court suggested that the more appropriate way to address issues of the type raised by plaintiff would be to deal with them specifically in the contract. The NIH could have included a time limit by when defendants should have developed the assay or the license would be revoked. Id.

Further, plaintiff failed to allege an essential element of negligent undertaking – reliance. Id. at *6. Plaintiff alleged that his status as a third-party beneficiary to the license agreement satisfied the reliance requirement, but he cited no authority for that proposition. So, closely adhering to the Erie doctrine, the court concluded that “If the courts of New Jersey believe that such an extension is appropriate, then they are in a better position to expand their own common law in the first instance.” Id.

This means plaintiff is back to his third amended complaint – failure to warn only. And as we just reported last week, there is good precedent on the adequacy of the Tysabri warnings and on Wyeth v. Levine preemption. And precedent has much more bearing in the courtroom than in the laundry room – where when prior rulings are cited to the judges they can be summarily ignored with a simple – “that was then, and I’ve changed my mind.”

 

We’ve talked a fair amount about forum shopping on this blog. Forum shopping is largely in the control of plaintiffs’ counsel because they, within reason, get to choose where to file their clients’ lawsuits. And since they do need some reason, there are several frequently used methods by plaintiffs’ counsel when they’ve narrowed in on the court they’ve decided would be most favorable for their clients – typically state court. If a plaintiff wants to stay in state court where he/she resides, he/she sues a non-diverse party. In drug and device cases, that’s usually a pharmacy, a sales representative, a doctor. Sometimes the joinder of such a defendant is fraudulent and the case becomes removal, sometimes not. Another option is to sue a defendant in state court where the defendant resides, a court from which the defendant cannot remove the case. While venue in that scenario may be proper, where the only connection to the jurisdiction is the presence of the defendant, defendants have met with mixed success in arguing forum non conveniens. Just think, if plaintiff lives in Nebraska, ingested the drug in Nebraska, suffered her injury in Nebraska, but files suit in New Jersey – where is most of the discovery that is needed located? Especially discovery from third-parties who will require subpoenas. What state’s law is likely to apply to the bulk of the claims?   Doesn’t make a lot of sense to be in New Jersey except for plaintiff’s preference to be in state court.

But what about when plaintiff’s choice of forum doesn’t turn out like he/she hoped? Should they get a do-over? A mulligan? A second chance? We don’t think so and neither did the court in Zarilli v. Johnson & Johnson, Docket No. ATL-L-1480-16, slip op. (N.J. Super. Law Div. Feb. 3, 2017). This case is one of several pending in New Jersey involving allegations of injury from the use of talc powder. The cases have been coordinated before a single judge for pre-trial proceedings. Plaintiff originally filed her suit in July 2016, and amended her complaint in September 2016. Defendants answered the complaint in October. Id. at 2.

Continue Reading Buyer Beware, No Buyer’s Remorse in New Jersey

Over the last couple of years, the Accutane mass tort in New Jersey state court has become the gift that keeps on giving.  The latest installment is a two-fer: In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super. Law. Div. Oct. 12, 2016), and In re Accutane Litigation, 2016 WL 5958375 (New Jersey Super. Law. Div. Oct. 12, 2016).  Between these two orders, practically every permutation of causation under the learned intermediary rule is addressed, and the end result is the grant of summary judgment against an impressive 160 of 162 plaintiffs.

For obvious reasons, we’ll call the first (#374) “Accutane I” and the second (#375) “Accutane II” to tell them apart.

Eighty-six plaintiffs’ cases failed in Accutane I because they couldn’t even begin to satisfy their usual burden of proof.  That was because, by the time they got around to bringing their lawsuits, their prescribing physicians had either died (44 plaintiffs) or else simply could not be located (42 plaintiffs).  2016 WL 5958374, at *1-2.  As we’ve discussed before, in one of our “little lists” posts, there’s now quite a bit of law enforcing the burden of proof in dead/missing prescriber cases.  We even feel somewhat paternal feelings in this area, because several of your merry bloggers (Eric A, Steve M, and Bexis), litigated this issue extensively a decade ago in Diet Drug cases at a time when there was practically no directly on-point precedent.  In doing so, we increased the number of favorable decisions from one to seven.

Accutane I represents another giant step forward. The court held that, under the law of no fewer than 35 jurisdictions, a plaintiff who could not obtain any prescriber testimony at all could not meet his/her burden under the learned intermediary rule (now the law, as we’ve pointed out, of all fifty states) of establishing that the absent prescriber would have changed the relevant prescription had s/he received a supposedly “adequate” warning.  The defendant’s causation argument was rather basic:

Defendants argue that without the testimony of the deceased or missing physicians, Plaintiffs cannot establish that [the drug] would not have been prescribed given a different warning and thus they cannot satisfy proximate cause. Absent physicians’ testimony, Defendants argue that the causal link to injury is broken.  Even if the proximate cause standard were as Plaintiffs claim – that their prescriber might hypothetically have altered their risk discussion somehow if only [the manufacturer] had warned differently – Defendants assert that physician testimony is still needed.

2016 WL 5958374, at *3 (citation omitted). Plaintiffs fell back on that old canard, the “heeding presumption.” Id. at *4.  The court, however, was having none of it.

[T]he Court is persuaded by Defendants’ arguments that the heeding presumption within a learned intermediary context does not equate with a decision by the physician to not prescribe the drug.  If it did, medications would never be prescribed when accompanied by warnings because of the various risks associated with their use.

. . .Plaintiffs concede that their physicians are deceased or otherwise unavailable, and they have offered nothing by way of individual opposition papers. . . . Accordingly, the case-specific facts presented by Defendants are undisputed.

Plaintiffs’ reasoning is flawed, especially when one considers the slew of risks associated with and heeded by [prescription drug] users and prescribing physicians. Notably, application of the heeding presumption in the context of a pharmaceutical learned intermediary case where a manufacturer provided a warning and its adequacy remains in issue is not reflected within any of the cited case law.

Id. at 10-11 (citation omitted) (emphasis added).  Regardless of any presumption, all plaintiffs “still have the burden of proof for every element of their claim.”

Continue Reading Warning Causation Potpourri in New Jersey Mass Tort